Malibu
Malibu Monoaxial Instrument and Implant Tray
1manufacturer
29catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | OJH |
| Device type | Orthopedic Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-05-02 |
| Record revised | 2025-10-24 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 91-2518 | In distribution | |
| 91-2619 | In distribution | |
| 91-2617 | In distribution | |
| 91-2523 | 4.5mm | In distribution |
| 91-2521 | In distribution | |
| MLB2INSTP | In distribution | |
| 91-2532 | 60mm – 110mm | In distribution |
| 91-2527 | In distribution | |
| 91-2530 | In distribution | |
| 91-2504 | In distribution | |
| 91-2534 | In distribution | |
| 91-2616 | In distribution | |
| PERSINSTP | In distribution | |
| 91-2531 | 35mm – 55mm | In distribution |
| 91-2430 | In distribution | |
| 91-2517 | 4.5mm | In distribution |
| 91-2615 | In distribution | |
| 91-2519 | In distribution | |
| 91-2618 | In distribution | |
| 91-2526 | In distribution | |
| 91-2516 | In distribution | |
| 91-2620 | In distribution | |
| 91-2525 | In distribution | |
| 91-2541 | In distribution | |
| 91-2520 | In distribution | |
| 91-2501 | In distribution | |
| 91-2502 | In distribution | |
| 91-2503 | In distribution | |
| 91-2522 | 5.5mm, 6.5mm & 7.5mm | In distribution |
Same Product Code
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|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 95,039 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53,097 |
| Avid TruCustom | Avid Medical, Inc. | 3,990 |
| ACS | American Contract Systems, Inc. | 3,812 |
| Halyard | Avid Medical, Inc. | 1,313 |
| Aligned Medical Solutions | Aligned Medical Solutions | 1,272 |
| Regard™ | ROi CPS LLC | 464 |
| Overwatch | Spinal Elements, Inc. | 223 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 191 |
| Lucent L | Spinal Elements, Inc. | 95 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 87 |
| Integra® | Ascension Orthopedics, Inc. | 81 |
Showing 12 of 367. All products under Orthopedic Tray
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.